Articles Posted in Defective Drugs

A tougher warning instituted by the US Food and Drug Administration this week cautions that azithromycin, a commonly prescribed antibiotic, most certainly can cause modifications to the heart’s electrical activity, which can cause some users to develop a deadly irregular heart rhythm. The federal agency had modified the drug’s warning labels last year.

Azithromycin (also known as Z-Pak) was requested in 55.3 million prescriptions last year alone. It is made by Pfizer.

This more stringent warning comes following the FDA’s review of a study published in the Spring of 2012 in the New England Journal of Medicine. Per the study, taking azithromycin over five days appears to slightly increase the changes of death compared to in other patients that were taking other antibiotics. Some of these azithromycin users suffered fatal heart attacks, cardiac death, strokes, and other cardiovascular conditions.

A federal jury wants Merck & Co. to pay $285,000 in the drug injury case filed by a plaintiff who contends that the manufacturer did not warn her doctors about the risks involved with taking Fosamax. However, the jury did not agree with Rhoda Scheinberg’s contention that the osteoporosis drug was defective. Her Fosamax injury attorneys argued that taking the drug caused her to sustain a bone disease of the jaw after she had a tooth extracted.

This trial is a bellwether case. According to Reuters, there are over 4,000 Fosamax lawsuits pending in state and federal courts from injuries allegedly resulting from use of this medication.

According to the jury, Merck’s failure to warn about the risks involved with taking Fosamax caused Scheinberg’s personal injury. However, following the verdict, an attorney for Merck stated that the manufacturer does, in fact, provide proper warnings and believes that whether or not Scheinberg had taken Fosamax, she still would have been at risk for developing jaw and dental problems.

According to a study found in The Journal of Clinical Endocrinology & Metabolism, patients who developed femur fractures linked to their use of bisphosphonates, including Fosamax, tend to experience pain before the actual fracture happens, a delay in healing, and the ongoing risk of a another fracture. This is just one more reminder of the serious side effects that can come from taking Fosamax, which is made by Merck.

The study’s authors, who include Dr. Jennifer Schneider, a physician who experienced a spontaneous thigh bone break while riding mass transit and had taken Fosamax, surveyed 81 people who belonged to an online Fosamax support group. The average participant had been taking bisphosphonates for 9.5 years, with more than half of them taking the medication to prevent bone breaks. Among the findings from their anonymously turned in medical data:

• 94% of participants had used only Fosamax and no other bisphosphonate.

November is National Diabetes Month, a time to promote greater awareness for the more than 20 million Americans who are living with this chronic illness that can lead to serious complications, including heart disease, blindness, high blood pressure, and stroke. At Altman & Altman, LLP, our drug injury lawyers are well aware of the health issues that patients suffering from diabetes can develop. One of the reasons for this is that we represent diabetes patients (and their families) that have developed bladder cancer after taking the medication Actos.

Already, numerous plaintiffs have filed Actos injury lawsuits suing Takeda Pharmaceuticals because they believe the diabetes drug caused their bladder cancer. There also have been studies confirming the link between Actos and this type of cancer. (Eli Lilly & Co., which marketed the diabetes drug for Takeda in the US, is also a common defendant.)

It wasn’t until 2011 that the US Food and drug Administration issued a safety communication notifying the public that Actos’s label had finally been modified to come with the warning that using the medication for longer than a year may significantly increase a patient’s chances of getting bladder cancer. The FDA especially wants people already suffering from blood cancer or who have a history of the disease to be very careful when taking Actos, or better yet refrain from taking medications with pioglitazone, which is the generic name of Actos. (On August 17th of this year, the FDA approved its first generic versions of Actos tablets. The manufacturer is Mylan Pharmaceuticals.)

A jury is ordering Novartis Pharmaceuticals Corp. to pay plaintiff Barbara Davids $10.45 million for osteonecrosis of the jaw injuries she says she sustained because she took the drug Zometa. The award is comprised of $450,000 in compensatory damages and $10 million in punitive damages.

Per her drug injury lawsuit, Davids claims that she developed bone death in her jaw after she took Zometa, which is a bisphosphonate that is used to treat bone complications resulting from cancer. Bisphosphonates, which are supposed to help with certain bone conditions, are now being linked to a greater risk of ONJ.

Davids believes that Novartis has known for some time that Zometa may cause serious jawbone complications. Her products liability lawyers even provided during trial an email from 2003 in which one of the pharmaceutical company’s marketing employees talks about a proposed report connecting the drug to the complications, describing it as very damaging. That employee also sent another email proposing a public relations imitative and other “next steps” in case the paper were to be published-although the ideal scenario appeared to be for it to never see the light of day.

Another dangerous drug lawsuit has been filed against Takeda Pharmaceuticals claiming that the drug Actos caused 14 plaintiffs to develop bladder cancer. All of the victims said they were diagnosed with this type of cancer after taking popular type 2 diabetes medication. Also named as defendants are the company’s subsidiaries and Eli Lilly.

In their Actos lawsuit, the victims are alleging negligent drug design and marketing. They contend that the defendants knew, or if they didn’t then they should have known, that taking Actos for a prolonged period increases the risk of bladder cancer. The plaintiffs want compensatory damages, including medical expenses and pain and suffering.

Although Actos has been available to diabetes users in the US for a number of years, it was just last year that the Food and Drug Administration put out a Drug Safety Communication giving notification that the medication’s label had been revised to include a warning that use of the drug for over a year dramatically increases the chances that the patient might develop bladder cancer. The federal agency’s safety announcement was issued after an examination of data belonging to a 5-year analysis of an Actos study that was conducted by Takeda. The FDA is now recommending that drugs with pioglitazone not be prescribed to people who already have blood cancer and that those with a history of the disease must be cautious should they choose to take this medication.

Also, there has been more than one study confirming the bladder cancer-Actos link. One of the more recent ones was just published in the Journal of the National Cancer Institute in August. Based on the study, which the National Institutes of Health funded, Researchers from the University of Pennsylvania’s Perelman School of Medicine are cautioning that thiazolidinedione users who take these drugs for five years or longer are at least twice as likely to receive a bladder cancer diagnosis than patients who are taking other diabetes medications. Actos is a thiazolidinedione medication.

Unfortunately this Actos-cancer connection was not revealed early enough for the many drug users who have developed cancer as a result. Consider how common a disease type 2 diabetes is-285 million are afflicted globally-and how many of these people have been prescribed Actos over the years. According to Upenn.edu, some 15 million Actos prescriptions are issued in the US each year.

For a medication to have such a serious side effect makes it a very dangerous drug. Already, hundreds of Actos lawsuits have been filed in US and state courts, with all federal cases consolidated in one court in Louisiana.

Diabetes Drugs Prescribed to More than 15 Million Americans Raises Risk of Bladder Cancer, Penn Medicine Study Shows, Penn Medicine, August 13, 2012

FDA Drug Safety Communication: Updated drug labels for pioglitazone-containing medicines, FDA, August 4, 2011

More Blog Posts:
Actos Lawsuits Allow Diabetes Patients to Pursue Dangerous Drug Compensation from Takeda Pharmaceuticals America, Inc., Drug Injury Lawyers Blog, August 1, 2012

Pradaxa Lawsuits Seek Damages for Bleeding Injuries, Drug Injury Lawyers Blog, July 25, 2012

Use of Ocella Birth Control Pill May Cause Higher Stroke Risk, Drug Injury Lawyers Blog, October 3, 2012 Continue reading

A little over a year after her death, the estate of Shirley Boles has reached a confidential damage award agreement with pharmaceutical giant Merck & Co. over injuries she sustained from the drug Fosamax. Boles developed osteonecrosis of the jaw after taking the medication for several years. She filed a Fosamax lawsuit, and, after an initial mistrial, a jury awarded her $8 million for her personal injuries. A district judge would go on to lower the award amount to $1.5 million while upholding the verdict. Boles decided to go to trial again. Now, however, her estate as instead consented to the damages agreement.

Boles is just one of hundreds of plaintiffs to sue Merck over claims that their bone injuries are result of taking Fosamax, which is a bisphosphonate and one of the more popular osteoporosis treatment and bone strengthening medications in use-by women, in particular. Fosamax is also used to treat other bone disorders and Paget’s disease. Unfortunately, Fosamax is now linked to very serious side effects, including atypical femur fractures, osteonecrosis of the jaw, serious musculoskeletal pain, esophageal cancer, atrial fibrillation, inflammatory eye disease.

Earlier this year, the US Food and Drug Administration published an analysis in the New England Journal of Medicine that warned about taking bisphosphonates long-term. The worry is that after using them for years, the drugs can cause certain women’s bones to become weaker, potentially leading to the serious side effects. The FDA also found that after conducting its own review of how effective bisphosphonates are after several years of use, beyond three to five years there was little, if any, additional benefit for most patients unless the person was older and had a higher fracture risk and a bone density that was “osteoporotic.”

The reason bisphosphonates are often prescribed to women is that after age 30 it is not uncommon for their bones to begin dissolving faster than they can be rebuilt-especially after menopause. Bisphosphonates are supposed to slow down this process.

Fosamax Lawsuits
For a drug that is supposed to strengthen bones to cause serious bone injuries as a dangerous defect. Not only must the patient contend with the complication, but also, there is the necessary treatment, rehabilitation, and, hopefully, recovery, that can take a toll on one’s physical, mental, emotional, and financial well-being. For example, among the more recent Fosamax cases is one filed by a woman who claims she experienced two femur fractures in her thighs after she started taking the medication. In addition to the thigh breaks, the plaintiff contends that taking Fosamax caused her to suffer other side effects that have necessitated ongoing medical care.

Bisphosphonates for Osteoporosis – Where Do We Go from Here, New England Journal of Medicine, May 31, 2012

FDA: Possible increased risk of thigh bone fracture with bisphosphonates, FDA, October 13, 2010

Bisphosphonates (Osteoporosis Drugs): Label Change – Atypical Fractures Update, FDA, October 13, 2012

More Blog Posts:
New FDA Report Suggests Exercising Caution About Using Fosamax Long-Term, Boston Injury Lawyer Blog, May 11, 2012

Meningitis Outbreak Linked to Massachusetts Pharma Company, Drug Injury Lawyers Blog, October 16, 2012

Use of Ocella Birth Control Pill May Cause Higher Stroke Risk, Drug Injury Lawyers Blog, October 3, 2012 Continue reading

According to The New York Times, fluoroquinolones, which are a class of antibiotics, may cause serious side effects. The most well-known of these meds are Avelox, Cipro, and Levaquin, which have been named in over 2,000 drug injury lawsuits.

Often, fluoroquinolones are not prescribed correctly and are used to treat bronchitis, sinusitis, earaches, and other illnesses that don’t require such strong medications instead of combatting more potentially fatal bacterial infections. According to pharmacological epidemiologist Dr. Mahyar Etminan, who is affiliated with the University of British Columbia, one reason for this is that some doctors opt to prescribe a more powerful drug when a much milder one is even warranted. Dr. Etminan was involved in a study that can be found in The Journal of the American Medical Association‘s April edition.

Per the study, patients who take fluoroquinolones have a five times greater chance of suffering from potentially blinding retinal detachment than those not taking this type of antibiotic. Etminan was also involved in another study in which he documented that fluoroquinolones users experienced an increase risk of kidney failure.

The Times article talks about one patient, Lloyd Balch, who experienced serious complications from Levaquin, which his doctor prescribed for him even after he brought up concerns about the possible side effects. Balch reportedly experienced weakness and pain after one dose and was instructed to take a second one, which led to joint pain and vision problems. He also has experienced problems walking, dry mouth, eyes, and skin, urine problems, eye burning, uncontrollable shaking, and muscle spasms.

Johnson & Johnson’s Ortho-McNeil-Janssen Pharmaceuticals, Inc. has been the defendant in numerous Levaquin injury lawsuits over has tendon ruptures and permanent tendon damage. Many of the plaintiffs are alleging a failure to warn of this side effect. (Fluoroquinolones do come with a “black box” warning about the tendinitis and ruptured tendon risks but some people believe such warnings aren’t always read.) Also, concerns over failure to warn have also been associated with retinal detachment.

Other serious injuries linked to fluoroquinolones include injuries to the central nervous system, heart, liver, gastrointestinal system, the musculoskeletal system, the renal system, and the visual system. They may even impact one’s blood sugar metabolism. Depression, psychotic reactions, hallucinations, phototoxicity, disfiguring rashes, Staphylococcus aureus, C. difficile infections, and severe diarrhea are also among the possible side effects.

Popular Antibiotics May Carry Serious Side Effects, New York Times, September 10, 2012

American Medical Association

FDA requires black-box warnings for fluoroquinolones

More Blog Posts:
Despite Actos Lawsuits, FDA Approves Type 2 Diabetes Drug’s Generic Version, Drug Injury Lawyers Blog, September 5, 2012

Severe Skin Reactions Caused by Stevens-Johnson Syndrome are Linked to Different Prescription and OTC Medications, Drug Injury Lawyers Blog, August 29, 2012

Boston Dangerous Drug Lawsuits: YAZ, Ocella, and Yasmin Birth Control Pills Linked to Deep Vein Thrombosis, Pulmonary Embolism, Stroke, Heart Attack, and Myocardial Infarction Side Effects, Boston Injury Lawyers Blog, June 19, 2012 Continue reading